NeuroStar Advanced Therapy System (Version 3.7)— 510(k) K230029

Substantially Equivalent

Neuronetics

FDA 510(k) clearance K230029 for NeuroStar Advanced Therapy System (Version 3.7), Substantially Equivalent on 2023-04-04. Applicant: Neuronetics.

Clearance details

Applicant: Neuronetics
Product code: Code OBP
Advisory panel: Neurology
Date received: 2023-01-04
Decision date: 2023-04-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Malvern, PA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code OBP

product code OBP

Injury: 270
Total: 270

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.